A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease

ConditionBrain Tumor - Metastatic

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Nebraska

About this trial

This study is being done to see if adding GLIADEL to the site where the tumor was removed works as well as just having the tumor removed with radiation treatment done within six weeks after the surgery to keep the cancer from coming back.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older (in states with 18 as age of majority); Age 19 years or older in Nebraska (age of majority)

Recursive partitioning analysis (RPA) class I, II or III with a Karnofsky Performance Status (KPS) of >/ 60

Known or suspected primary solid cancer with metastatic brain tumor(s) - up to four in number and up to 4 cm in size with surgical resection planned for at least one site with Gliadel placement planned for only one site

Laboratory values adequate for patient to undergo surgery safely as determined by the attending neurosurgeon (transfusion permitted to reach goals)

Disqualifiers

Prior treatment to the area of planned resection (surgery, radiation)

Prior whole brain radiation therapy

Diagnosis of lymphoma, germ cell cancer, small cell lung cancer, anaplastic thyroid cancer

Leptomeningeal disease

Trial design

Design model

Parallel

Treatments tested in this trial

Carmustine 7.7Mg Wafer
Drug
GLIADEL wafers will be placed to cover tumor bed immediately after tumor removal.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Standard of Care ArmNo intervention 0 interventions

Group B: GLIADEL ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Efficacy of GLIADEL compared to Stereotactic Radiosurgery (SRS)

The primary outcome is to evaluate the efficacy of GLIADEL local chemotherapy compared to Stereotactic Radiosurgery (SRS) in preventing local recurrence after resection of a metastatic brain tumor (local recurrence at surgical site).

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nebraska

Lead sponsor

Arbor Pharmaceuticals, Inc.

Collaborator

Source ClinicalTrials.gov

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